MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	A-91501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a allen lift assist beach chair extension ¿gave way¿ and the patient fell.The patient was admitted to the hospital for an emergency left acromioclavicular (ac) joint separation procedure.The patient was intubated and sedated.Prior to the end of the procedure, the medical staff were adjusting the table extension and the table extension ¿gave way.¿ the patient started falling headfirst; however, the surgeon and nurses were able to ¿partially controlled the fall.¿ the patient did end up falling and hitting their head.The patient sustained a ¿small laceration¿ to their head.The endotracheal tube remained intact, and the patient remained hemodynamically stable.The medical emergency team (met) were called to have additional staff to assist in the surgical theater.Spinal precaution protocols were put in place and the team was able to safely return the patient to the table.The patient remained intubated and was transferred to radiology for an urgent computed tomography scan (ct) brain and neck.Ct results were clear.The patient remained in full spinal precautions overnight until a full tertiary survey could be completed.The following day, the patient was cleared and consented to complete the surgical procedure.No further information was available at the time of this report.
Additional Manufacturer Narrative
E1: initial reporter postal code: (b)(6).H11: baxter is in the process of inspecting the beach chair.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 and h11 h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photographic samples provided did not identify any abnormalities that could have contributed to the reported condition.Additionally, according to the design of this device the expected life for the a-91501 is 5 years.The a-91501 associated with this complaint was more than 5 years old; therefore, the alleged deficiency is considered normal wear.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ALLEN
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22321227
• Report Number: 3010216206-2025-00014
• Device Sequence Number: 8818589
• Product Code: FWZ
• UDI-Device Identifier: 00615521004125
• UDI-Public: (01)00615521004125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A-91501
• Device Catalogue Number: A-91501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 24 YR
• Patient Sex: Male